Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease… (NCT07416383) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease Patients
40 participantsStarted 2026-04-01
Plain-language summary
Inflammatory bowel disease patients who failed from at least two types of biologics or suffered refractory after at least twice surgery are defiened as difficult-to-treat IBD. It is reported a low five-year suvival rate around 15% of difficult-to-treat IBD patients. Cell therapy is a promising new strategy in auto-immune diseases beyond malignant cancers. Inbalanced immune microenvironment contribute to IBD and cell therapy should be a brighting selection of difficult-to-treat IBD. CNK-UT009 is an universal cellular immunotherapy targeted to auto-reactive T cells whose safety and effect were proved in patients with GVHD and type 1 diabetes mellius. Here, we conducted a single-arm open-label exploratory clinical study of CNK-UT cell therapy on difficult-to-treat IBD patients, mainly to explore the safety and define the maximum tolerated dose. Besides, the preliminary effect would also be evaluated.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* diagnosed moderate-to- severe IBD patients
* defiened as difficult-to-treat(failed from at least two types of biologics or small molecular drugs, or refractory from at least twice of intestinal surgery)
* with complete bone-marrow and organic function
* no pregnant or planning to become pregnant
* welling to paticipate
Exclusion Criteria:
* patients with active infections or latent infections, malignant tumors, recent serious infections(within two weeks)
* patients paticipated other clinical trials with four weeks
* patients with drug combination other than low-dose glucocotiod
* patients recieved abdominal surgery or live vaccine
* patients with planned surgery in three months
* unsuitable situations determined by researchers
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
maximum tolerant dose(MTD)
Timeframe: 12 weeks after first injection
2
rate of DLT(dose-limiting toxicity)
Timeframe: 12 weeks after first injection
Trial details
NCT IDNCT07416383
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University